Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:

to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision. [ Time Frame: indefinate ] [ Designated as safety issue: Yes ]

Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total of up to 4 injections.

After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility

Ages Eligible for Study:

6 Months to 18 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of macrocystic lymphangioma of the head and/or neck Cystic spaces at least 2.0 mL confirmed by radiographic imaging (MRI or CT) Mixed lymphangiomas (macrocystic and microcystic disease) allowed if macrocystic component comprises at least 50% of the total disease burden

Renal: No clinically significant renal disease No personal or family history of post-streptococcal glomerulonephritis

Cardiovascular: No personal or family history of rheumatic heart disease

Pulmonary: No respiratory failure

Other:

Not pregnant or nursing

Negative pregnancy test

No history of allergy to penicillin

No concurrent temperature of 100.5 degrees or greater

No active upper respiratory infection

No personal or family history of obsessive-compulsive or tic disorders

No personal or family history of PANDA (pediatric autoimmune neuro- psychiatric disorder associated with streptococcal infections)

No history of hypersensitivity to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)

No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010452